Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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Nasal High Flow in Early Management of Patients Admitted to the Emergency Department for Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis : a Randomized Controlled Non Inferiority Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to determine whether nasal high flow is non inferior to non invasive ventilation (NIV) in the early treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and hypercapnic acidosis in the emergency department (ED). After obtaining informed consent, participants will be randomly assigned to receive either nasal high flow or non invasive ventilation (NIV, reference treatment) as respiratory support. Researchers will compare both respiratory support groups to see if their blood gas analysis and respiration return to normal ranges.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patients with ability to understand and give an informed consent

• Patients affiliated with or who benefit from a social security

• Patients admitted to the emergency department for a clinical suspicion of AE-COPD based on clinical history, physical examination and chest X-ray (SPLF 2017)

• Patients with acute respiratory failure defined by: Respiratory rate ≥ 25 bpm AND/OR Signs of respiratory failure (use of accessory respiratory muscles, paradoxical abdominal movement)

• Patients with respiratory acidosis defined by PaCO2 \> 45 mmHg AND pH \< 7.35 (measured on arterial blood gas)

Locations
Other Locations
France
Montpellier University Hospital
RECRUITING
Montpellier
Centre hospitalier universitaire de Nimes
NOT_YET_RECRUITING
Nîmes
Centre Hospitalier Universitaire de Poitiers
NOT_YET_RECRUITING
Poitiers
Contact Information
Primary
Mustapha Sebbane, MD, PhD
m-sebbane@chu-montpellier.fr
+33 (4) 67 33 85 76
Backup
Sophie LEFEBVRE, PhD
s-lefebvre@chu-montpellier.fr
+33 (4) 67 33 85 76
Time Frame
Start Date: 2026-06-16
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 174
Treatments
Experimental: Nasal high flow
Nasal high flow will be administered through a heated humidifier (Airvo 3, Fisher and Paykel healthcare) and applied through large bore binasal prongs.~Initial gas flow rate will be set at 60 l/min, FiO2 will be adjusted to maintain an SpO2 88-92% and Initial temperature will be set at 37° and reduced according to patient's tolerance.~Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment
Active_comparator: Non invasive ventilation
NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode.~The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 88-92% and to patient's comfort.~Ventilatory support will be applied in 2h sessions and resumed as needed according to international guidelines for NIV treatment.
Sponsors
Leads: University Hospital, Montpellier
Collaborators: Fisher and Paykel Healthcare

This content was sourced from clinicaltrials.gov